For doctors

TWYNSTA tablets contain two active substances called telmisartan and amlodipine. Both of these substances help to control your high blood pressure:

Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II.

Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stopscalcium from moving into the blood vessel wall which stops the blood vessels from tightening. This means that both of these active substances work together to help stop your blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.

TWYNSTAis used to treat high blood pressure

in adult patients whose blood pressure is not controlled enough with amlodipine.

in adult patients who already receive telmisartan and amlodipine from separate tablets and who wishto take instead the same doses in one tablet for convenience.

High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

if you are allergic (hypersensitive) to telmisartan or amlodipine or any other ingredient included in TWYNSTA tablets (see section Further information for a list of other ingredients)

if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker)

if you are more than 3 months pregnant. (It is also better to avoid TWYNSTA in early pregnancy – see Take special care with TWYNSTA and Pregnancy section.)

if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder)

if you suffer from severe low blood pressure (including shock)

if you suffer from low heart output because of a serious heart problem

If any of the above applies to you, tell your doctor or pharmacist before taking TWYNSTA.

Take special care with TWYNSTA

Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

Kidney disease or kidney transplant

Narrowing of the blood vessels to one or both kidneys (renal artery stenosis)

Liver disease

Heart trouble

Raised aldosterone levels (which lead to water and salt retention in the body along with imbalance of various blood minerals)

Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting

Elevated potassium levels in your blood

Diabetes

Narrowing of the aorta (aortic stenosis)

Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris)

A heart attack within the last four weeks

In case of surgery or anaesthesia, you should tell your doctor that you are taking TWYNSTA.

Children The use of TWYNSTA in children and adolescents up to the age of 18 years is not recommended.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with TWYNSTA:

Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole)

Erythromycin (antibiotic)

Diltiazem (cardiac medicine)

As with other blood pressure lowering medicines, the effect of TWYNSTA may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.

TWYNSTA may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, neuroleptics or antidepressants). Further low blood pressure may be aggravated by alcohol. You may notice this as dizziness when standing up.

Taking TWYNSTA with food and drink

You can take TWYNSTA with water or other non alcoholic drink and with or without food.

Pregnancy and breastfeeding PregnancyYou must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking TWYNSTA before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of TWYNSTA. TWYNSTA is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

BreastfeedingTell your doctor if you are breastfeeding or about to start breastfeeding. TWYNSTA is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.

Ask your doctor of pharmacist for advice before taking any medicine.

Driving and using machines

Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, do not drive or use machines.

Important information about some of the ingredients of TWYNSTA

TWYNSTA contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TWYNSTA It is important that you take TWYNSTAevery day until your doctor tells you otherwise. If you have the impression that the effect of Twynsta is too strong or too weak, talk to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, TWYNSTA can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.

Do not use TWYNSTA after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture. Remove your TWYNSTA tablet from the blister only directly prior to intake.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over). ‘Essential’ means that the hypertension has no obvious cause.

Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone. Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.

Twynsta is taken by mouth as one tablet once a day and is used for long-term treatment. The maximum dose is one tablet of the highest strength (80/10 mg) once a day.

For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Twynsta. When appropriate, direct switch to Twynsta may be considered.

For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.

Twynsta contains two active substances, telmisartan and amlodipine. Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

Telmisartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.

Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.

In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment). In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Twynsta or continued to take amlodipine at the same or a higher dose. The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.

Studies were also carried to show that Twynsta tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.

In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.

In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.

The most common side effects with Twynsta (seen in more than 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet). For the full list of all side effects reported with Twynsta, see the package leaflet.

Twynsta should not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives’ class or to any of the other ingredients. It must not be used in women who are more than three months pregnant. Twynsta must also not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), severe hypotension (low blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).

The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta. In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone. The Committee decided that Twynsta’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the EU for Twynsta to Boehringer Ingelheim International GmbH on 7 October 2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.